Evidence map›Paper›PMID 29651711›Full record

ArticleCNS drugs2018

Baclofen to Prevent Relapse in Gamma-Hydroxybutyrate (GHB)-Dependent Patients: A Multicentre, Open-Label, Non-Randomized, Controlled Trial.

Harmen Beurmanjer, Rama M Kamal, Cor A J de Jong, Boukje A G Dijkstra, Arnt F A Schellekens

Open access · hybridAbstract readControlled Clinical TrialMulticenter Study
In one paragraph

Article in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Characterization of the GHB Withdrawal Syndrome.Journal of clinical medicine · 2021
    Article
  6. Observational
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Harmen BeurmanjerNovadic-Kentron, Vught, The Netherlands. harmen.beurmanjer@novadic-kentron.nl.ORCID 0000-0003-1864-1589
Rama M KamalGGZE, Eindhoven, The Netherlands.
Cor A J de JongNijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Nijmegen, The Netherlands.
Boukje A G DijkstraNovadic-Kentron, Vught, The Netherlands.
Arnt F A SchellekensNijmegen Institute for Scientist-Practitioners in Addiction (NISPA), Nijmegen, The Netherlands.
Nijmegen Institute for Scientist Practitioners in Addiction · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGamma-hydroxybutyrate (GHB) dependence is associated with a severe, potentially lethal, withdrawal syndrome and relapse rates as high as 60% within 3 months of detoxification. Baclofen has been shown to decrease self-administration of GHB in mice and reduce relapse in a case series of GHB-dependent patients. Controlled studies on the effectiveness of baclofen to prevent relapse in GHB-dependent patients are lacking.

aimThe aim of this study was to assess effectiveness of baclofen in preventing relapse in GHB-dependent patients.

methodsThis was an out-patient, multicentre, open-label, non-randomized, controlled trial in GHB-dependent patients (n = 107) in the Netherlands. Treatment as usual (TAU, n = 70) was compared with TAU plus baclofen 45-60 mg/day for 3 months (n = 37). Outcome measures were rates of lapse (any use) and relapse (using GHB on average once a week or more), based on self-report. Side effects were monitored with a baclofen side-effects questionnaire. Treatment groups were compared using Chi square analyses, with both per-protocol (PP) and intention-to-treat (ITT) analyses.

resultsGHB-dependent patients treated with baclofen after detoxification showed no reduced lapse rates, but reduced relapse and dropout rates, compared with patients receiving TAU only (24 vs 50%). While both ITT and PP analyses revealed similar results, the effectiveness of baclofen prescribed PP was slightly higher than in ITT analysis. Patients reported overall limited side effects, with the most frequently reported being feeling tired (28%), sleepiness (14%) and feeling depressed (14%). No serious adverse events were reported.

conclusionsThis study showed potential effectiveness of baclofen in preventing relapse in patients with GHB dependence after detoxification. Though promising, future studies with longer follow-up and a randomized double-blind design should confirm these findings before recommendations for clinical practice can be made. CLINICAL

trial registrationNetherlands Trial Register with number NTR4528.

Indexed as

Sodium OxybateAdultAmbulatory CareBaclofenFemaleGABA-B Receptor AgonistsHumansMaleSecondary PreventionSubstance-Related DisordersTreatment OutcomeBaclofenGABA-B Receptor AgonistsSodium Oxybate

Identifiers

PMID29651711
PMCPMC5976688
OpenAlexW2797581966

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.